AWERB Annual Summary Report 2023 

Introduction 

The role of the Animal Welfare and Ethical Review Body (AWERB) is to provide advice and support to licence holders and named persons, ensuring that research involving animals is carried out to high ethical standards and that the principles of the 3Rs (replacement, reduction and refinement) are applied to everything that we do. 

AWERB meetings are held four times per year and follow a standard agenda which includes reports from individuals with “Named Person” responsibilities under ASPA, and ethical review of proposed, amended, and ongoing research.  AWERB also considers all other matters in relation to research involving animals including training, facilities, resources, and communications (openness about animal research). 

Task 1 of AWERB 

To advise staff dealing with animals on matters related to the welfare of animals, in relation to their acquisition, accommodation, care and use. 

• All Named Persons provided an oral report to each meeting detailing activities within the establishment, including but not limited to, the welfare of animals, in relation to their acquisition, accommodation, care and use.  The group then had opportunity to ask questions and provide advice. 
• The Named Animal Care and Welfare Officer (NACWO) provided detailed reports on ongoing experiments, breeding programmes, and some minor health issues. 
• The Named Veterinary Surgeon (NVS) provided a regular report on animal health checks/ status. 
• The Home Office Liaison Contact (HOLC) provided detailed reports in relation to animal accommodation, including facilities and security. 
• The Procedure Establishment Licence (PEL) was reviewed and updated to remove unused rooms. 
• Multiple Estates projects have been discussed, including the upgrade of equipment to maintain suitable room conditions and some cosmetic refurbishment, there is an ongoing dialogue and improved understanding of BSU needs with the new Director of Infrastructure. 
• The HOLC reported on requests for information, in 2023 there were four requests under Freedom of Information legislation and one enquiry through a different route.  Two requests did not require a response, two were able to be referred to the website, and one was dealt with by the FOI team who provided a personal reply. 

Task 3 of AWERB 

To establish and review management and operational processes for monitoring, reporting and follow-up in relation to the welfare of animals housed or used in the licensed establishment. 

• The HOLC reports to AWERB on all audit activity and matters of non-compliance. 
• During 2023, an ASRU Inspector attended to undertake an announced Facilities Audit and an HSE Inspector attended to undertake an announced Genetically Modified Organisms (Controlled Use) audit. 
• ASRU provided a template Facilities Audit Report and preparations were discussed at AWERB.  Gap analysis of compliance with all standard conditions was already ongoing and the risk register was being utilised. 
• Both audits went well with only one action and one recommendation being identified. 
• A non-compliance was reported to ASRU.  Behavioural tests were conducted on a group of 36 mice without correct licence authority. The individual involved was trained and competent to perform the test, but they were not permitted in this case.  The PPL holder attended the October meeting and detailed the non-compliance in their mid-term report.  The incident was self-reported to ASRU, and animal welfare was not impacted – ASRU issued “Inspector Advice”. 
• The NACWO provided details of exceeded severity, and each case was discussed with any necessary actions being identified. 
• During 2023 there were 6 reports of exceeded severity, all of which were reported to ASRU and were accepted with no further actions being required. 
• The Risk Register is now a standard agenda item. 
• AWERB membership requirements and routes of recruitment were discussed, and the ToR updated to increase membership. 

• Other new documents or processes discussed were; 
  • Introduction of an Induction Checklist for AWERB members (agreed to proceed). 
  • Move of health reporting to a SharePoint file accessible to all Named Persons (in use). 
  • Introduction of a standardised Study Schedule (in trial phase). 
  • Introduction of an Annual Summary Report for public sharing (in development with the user group). 
  • Introduction of a rehoming policy (advice being sought from Information Governance team). 
  • Introduction of a documented 3Rs strategy (advice being sought from Information Governance team) 
• The Establishment Licence Holder (PELh) reported to the July meeting that they would be leaving the University and a replacement would be identified.  The replacement was interviewed by ASRU and the Home Office inspectorate and confirmed in post before the October meeting. The new PELh completed the necessary Home Office training course in November 2023. 
• A review of AWERB membership was discussed and proposals to increase lay membership and regroup scientific members and licence holders was approved.  These changes to the Terms of Reference were also approved by the Ethics Committee. 
• The Terms of Reference, and Operation and Organisation Document were reviewed. 

Task 5 of AWERB 

To advise on re-homing schemes, including the appropriate socialisation of the animals to be re-homed. 

• Introduction of a rehoming policy or procedure was considered, and advice is being sought from the Information Governance team. 

Task 6 of AWERB (additional task) 

To advise the establishment licence holder whether to support project proposals, primarily considering such proposals from a local perspective and bringing local knowledge and local expertise to bear. 

• The Operation and Organisation of AWERB document sets out the procedure to be followed for ethical review of all new projects, including those that do not involve any regulated procedures but do make use of the organs and tissues of animals for a scientific purpose (Schedule 1 work). 
• Applications are generally discussed with the NACWO and NVS, as well as other experts or collaborators before reaching the formal ethical review process. 
• For Project Licence applications, there is a two-stage review process which involves an initial presentation to the full AWERB and then a detailed review during which AWERB members will have opportunity to comment on any aspect of the project and the applicant will need to provide a satisfactory response to any issues raised. 
• The whole process can take several months and must be completed to the satisfaction of the Named Persons before the application can progress to a Home Office Inspector. 
• During 2023 one application was rejected due to a statement that the primary purpose of the project was teaching.  Other projects discussed at AWERB meetings in 2023 were;  
• Project Licence “epigenetics of skin development, pigmentation, and cancer” was approved in principle and allowed to progress to detailed ethical review following an introductory presentation. 
• Project Licence “epigenetics of skin cancer using xenograft models” was approved in principle and allowed to progress to detailed ethical review following an introductory presentation. 
• A Schedule 1 project “Development of naked mole rat brain extracellular matrix” was approved by a subcommittee and reported to AWERB. 
• A Schedule 1 project “Induction of the HPG axis in naked mole rats” was approved by a subcommittee and reported to AWERB. 
• A Schedule 1 project “Characterising skin and hair follicle in naked mole rats” was approved by a subcommittee and reported to AWERB. 
• Project Licence “Perineuronal net as a neuroprotective factor in Parkinson’s disease progression” was approved in principle and allowed to progress to detailed ethical review following an introductory presentation. 
• A Schedule 1 project “Establishing primary perineuronal net neuronal culture for Parkinson’s and perineuronal net research” was approved by a subcommittee and reported to AWERB. 
• A Schedule 1 project “Evaluating autoantigens in alopecia areata” was approved by AWERB. 
• An application for involvement in an ongoing overseas collaboration “Serum miRNAs for murine germ cell cancer detection” was approved by AWERB. 
• In each case the relevant ethical review process (ERP) application form was circulated to AWERB members for consideration. 
• In the case of project licence applications, a more detailed review of the full application were undertaken by a subcommittee who made a recommendations to the PELh and reported the outcome of the review to a later AWERB meeting.